DEVICE: Advocate (05397132007652)

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Device Identifier (DI) Information

Advocate
A35100020075

ARRAVASC LIMITED
05397132007652
GS1
1
Advocate 0.035” PTA Catheter (10.0mm x 20mm x 750mm)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LIT Catheter, Angioplasty, Peripheral, Transluminal
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a dark, dry, cool place. Avoid extended exposure to light, organic solvents, ionizing radiation or ultraviolet light
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Clinically Relevant Size

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Size Type Text
Length: 20 Millimeter
Outer Diameter: 10.0 Millimeter
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Device Status

In Commercial Distribution
September 13, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+353091758939
cs@arravasc.com
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